Allergan LAP-BAND

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

The authors write, “Between March 1993 and June 1999, 123 patients underwent either open (36) or laparoscopic (87) surgery for morbid obesity by the application of an adjustable gastric band.” Upon evaluation, doctors found that “54% of patients experienced postoperative complications requiring hospital treatment >or= 7 days, and 52% underwent a reoperation.”

In all, one third of the implanted gastric bands were removed for one reason or another. Doctors write that “The most important late complications were esophagitis (30%), obstruction due to slippage / pouch dilatation (21%), incisional hernia (9%) and band erosion (9%).”

According to the Bariatric Analysis and Reporting Outcome System, “the outcome was regarded as “very good” in 3%, “good” in 7%, “fair” in 40% and “failure” in 50%.”

Reports such as this can be used in a LAP-BAND lawsuit, as first, complication rates and reoperation rates are shown to be much higher than reported in the LAP-BAND Warning Label, and second, it is clear that the manufacturer of these products, Allergan, knew – or should have known, the risks associated with its product but failed to act.

If you or a loved one used a LAP-BAND and suffered complications as a result, you too may be entitled to significant financial compensation for your injury. For a free, no-obligation case consultation, contact our team of LAP-BAND lawyers at the information provided below. We have the compassion, resources, and experience required to win the justice you deserve. Call today and see how we can help.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

The authors write, “Laparoscopic adjustable gastric banding (LAGB) remains the most popular bariatric procedure performed in Australia and Europe” and “Gastric band erosion is a significant complication that results in band removal.” So, “The aim of this study is to assess the prevalence of band erosion and its subsequent management with a particular focus on rebanding results.”

In all, the authors identified 1,874 patients who underwent gastric banding between August 1996 and October 2010. It was found that band erosion (migration of the band) occurred in 63 patients – 3.4%. It ought to be noted that this is more than twice the rate as that disclosed in the LAP-BAND Warning Label, which assumes erosion will only occur in about 1.33% of patients.

Concerning the patients in whom LAP-BAND erosion took place, the study team writes “Symptoms included abdominal pain in 24 (38%), obstruction in 7 (11%), recurrent port infection in 5 (8%), reflux symptoms in 2 (3%) and sepsis in 2 (3%). Fourteen patients (22%) had discolouration of the fluid in their band. Endoscopic removal was attempted in 50 patients with successful removal in 46 (92%).” They also state that “Rebanding was performed in 29 patients and 5 (17%) experienced a second erosion.”

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

Bueter et al. (2008) write “Today, gastric banding has become a common bariatric procedure. Weight loss can be excellent, but is not sufficient in a significant proportion of patients” and “Few long-term studies have been published.”

This study consisted of 127 patients who underwent gastric banding between 1997 and 2004. After a mean follow-up of 63 months “(range 2-104)”, rates for various complications were as follows: “gastric perforation in 3.1%, band erosion in 3.1%, band or port leak in 2.3%, port infection in 5.3%, port dislocation in 6.9%, and pouch dilatation in 16.9%.” It was also found that 26.7% of patients required reoperation.

Though mean excess weight loss was just above 50% in this group, these complication rates and reoperation rates are significantly higher than those reported by Allergan for the LAP-BAND gastric banding system. The warning label for LAP-BAND estimates that about 5% of patients will require reoperation, and that erosion, for example will only occur in 1.33% of LAP-BAND patients.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

The team writes “Between June 1997 and June 2003, LGB was performed in 317 patients, 43 men and 274 women,” of whom about 98% were available for follow-up at 3 years, “88.2% after 5 years, and 81.5% after 7 years. Overall, 105 (33.1%) of the patients developed late complications, including band erosion in 9.5%, pouch dilatation/slippage in 6.3%, and catheter- or port-related problems in 7.6%. Major reoperation was required in 21.7% of the patients.”

As such, the team concluded that “With a nearly 40% 5-year failure rate, and a 43% 7-year success rate ([excess weight loss] >50%), LGB should no longer be considered as the procedure of choice for obesity” and warn that the procedure shouldn’t be used until doctors have determined which patients might be at low risk for complications.

Due to the fact that Allergan, the manufacturer of LAP-BAND, a popular gastric banding system, reports significantly lower rates of complications than those determined by Suter et al. in 2006, a number of LAP-BAND lawsuits were filed.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

The authors write “Laparoscopic application of an adjustable gastric band (LAGB) is considered the least invasive surgical option for morbid obesity,” and though they state “It has the advantage of being potentially reversible and can improve quality of life,” gastric banding does not come without the risk for serious complications.

Of the 400 patients reviewed in this study, 10% required revision surgery for complications including perforation, gastric necrosis, slippage, incisional hernia, and reconnection of the tube. There were also “7 pulmonary complications (2 ARDS, 5 atelectasis) and 30 minor problems related to the access port.” Thirty-one of the forty complications requiring surgery were cases of gastric band slippage.

While no medical procedure goes without risk, it is important for all patients to be aware of relevant risks and the rates at which complications occur. Allergan, the manufacturer of LAP-BAND, a popular gastric banding system, has failed to accurately portray the risk rates for its product, stating that only about about 4.6% of patients would require reoperation — less than half the rate found by Chevallier et al. (2002).

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

While this study found that in general, conversions went well and patient weight loss continued with gastric bypass in a comparable way, it also revealed some important information about the safety of laparoscopic adjustable gastric banding with systems such as LAP-BAND.

The Allergan LAP-BAND Warning Label states that about 1.33% of patients will suffer LAP-BAND migration (erosion), but this study found that of 347 patients, 6.8% suffered LAP-BAND erosion, an erosion rate about five times higher than advertised.

Due to the fact that Allergan, the manufacturer of the LAP-BAND, has failed time and again to accurately portray the rate at which serious complications are associated with its product, a number of LAP-BAND lawsuits are currently being filed against the company.

Our Allergan LAP-BAND Lawsuit Information page is a great place to start if you have any questions about the Allergan LAP-BAND.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

While average length of stay in the hospital was significantly shorter in the laparoscopic adjustable gastric banding (LGAB) group than in the vertical banded gastroplasty (VBG) group, and three LGAB patients were converted to gastric bypass procedures, the authors write that “Directly after VBG, 3 patients needed relaparotomies due to leakage, of which one (2%) died.”

Vertical banded gastroplasty was found to be more effective in weight loss, but more patients using LGAB required revisional surgery than did VBG patients (18 vs. 20). The authors write “2 years after LAGB, 20 patients needed reoperation for pouch dilation/slippage (n=12), band leakage (n=2), band erosion (n=2) and access-port problems (n=4). In the VBG group, 18 patients needed revisional surgery due to staple-line disruption (n=15), narrow outlet (n=2) or insufficient weight loss (n=1). Furthermore, 8 VBG patients developed an incisional hernia.”

Sadly, the manufacturer of the LAP-BAND (a common LAGB system), Allergan, reports drastically lower rates of complications and reoperations in its LAP-BAND Warning Label.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

Laparoscopic adjustable gastric banding is a surgical process by which an adjustable plastic band is placed around the stomach, thus limiting the size of the stomach and causing patients to feel full after having consumed less food.

Due to the fact that the LAP-BAND Warning Label suggests a significantly lower portion of patients are expected to face complications or require reoperation, a number of LAP-BAND lawsuits are currently being filed.

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

For this study, Martin et al. (2007) “reviewed 2 multicenter prospective, open-label, single-arm surgical trials–trial A (3 years) and trial B (1 year)–with ongoing safety follow-up.” The first trial included 292 patients, and the second included 193 patients. Researchers write that about 70% and and 73% of the patients completed the 3- and 1-year follow-up periods, respectively.

While this team found gastric banding to be effective in weight loss, there were a high number of complications observed. “The percentage of initial body weight lost at 1 year was 17.7% +/- 9.4% for trial A subjects and 18.2% +/- 8.9% for trial B subjects, whereas the 3-year total for trial A subjects was 18.3% +/- 13.1%.”

Concerning complications, “At 1 year, 76% of patients in trial A and 66% of patients in trial B had complications, mostly related to upper gastrointestinal symptoms. By 9 years after surgery, 33% (96 of 292) of trial A subjects had their devices explanted because of complications or inadequate weight loss.”

We are no longer accepting cases regarding these products. Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device. We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers. For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.“

In a 2002 paper by FD Capizzi et al. titled “Laparoscopic adjustable esophagogastric banding: preliminary results.” published in Obesity Surgery, it is written “Laparoscopic gastric banding is effective in surgical treatment of morbid obesity, but has had the drawback of specific complications, like slippage and gastric erosion. To prevent such complications, modifications have been used, including high retrogastric positioning above the bursa omentalis, complete anterior fixation by gastro-gastric stitches over the band, and reduction of the pouch volume to < or = 15 ml” and “These technical variants may induce dysphagia.”

To study the safety and efficacy of this LAP-BAND technique, Capizzi et al. (2002) reviewed 80 consecutive patients who had undergone laparoscopic adjustable esophagogastric banding between January 1999 and March 2001 at an Italian hospital.

Concerning efficacy, doctors found that “Mean BMI decreased from 45 to 38 after 6 months, remaining at 37 after 24 months, while excess weight was reduced by 50% at 24 months.”

“Complications included 2 cases of slippage: an early one after 24 h, requiring surgical removal, and a late one after 9 months, treated by laparoscopic repositioning. The third complication, a reactive esophageal stenosis, occurred in a transsexual male on estrogen treatment, that needed replacement with a wider Swedish band.” It is also stated that “Band adjustment was required in 28 patients, one time in 22 cases and twice in the other 6”, representing a 35% reoperation rate.

Due to the fact that reoperations rates such as this have been determined by independent researchers to be significantly higher than those reported in the LAP-BAND Warning Label, a number of LAP-BAND lawsuits have been filed.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.